PLM's Antidote to Med Device Makers' Compliance Woes

Of all the industries facing serious challenges around regulatory compliance, the medical device sector appears to be caught in a particularly thorny trap.

On the one hand, manufacturers in this space are up against unprecedented pressures to get more and more innovative products to market faster on a global basis. At the same time, however, new regulations continue to emerge, making it increasingly difficult to balance the call for innovative engineering with the ongoing demands for proven and rigorous compliance practices.

The problem has become so acute it's caught the attention of the C-level suite. According to a January 2012 survey by Emergo Group, the No. 1 concern among CEOs in the medical device sector is changing regulatory requirements (53 percent) -- a bigger priority and problem than access to capital and credit (40.9 percent), new product development (38.9 percent), and increased competition (23.2 percent). Tougher measures put forth by the Food and Drug Administration (FDA) over the last few years have further complicated matters. To wit: During the period from 2007 to 2010, reports show that the average time for approval on a medical device application has increased by 43 percent, and the increased pace of regulatory change means that 15 percent to 20 percent of all medical device companies' R&D budgets are now being allocated to help manage change, not necessarily facilitate new product introductions (NPI).

The pressure to meet rigorous compliance requirements is forcing small shops like Livengood to put document control and design processes in place that would seem better suited to larger medical device companies. (Source: Livengood)

"Everyone thinks they have compliance issues, but if you walk into a medical device company, the problem is exacerbated," Peter Schroer, president and CEO at PLM provider Aras Corp., told me. "There's so much more traceability required behind every decision."

To be sure, medical device makers are facing a regular alphabet soup of global directives, from environmental regulations like RoHS, WEEE, and REACH, to a litany of document and requirements traceability standards. Two of the more stringent requirements around compliance involve creating and maintaining the Device Master Record (DMR), which captures every part, drawing, document, work instruction, and processing instruction related to the development of a medical device; and the Design History File (DHF), which maintains a complete record of design decisions around a product, from the planning phase throughout any changes made during manufacturing.

In fact, the lack of formal DMRs and DHFs are among the top 10 reasons the FDA cites for issuing non-conformance directives to medical device makers requesting regulatory approval for new product introductions. Other common roadblocks include the lack of a corrective action/preventive action (CAPA) system, inadequate management controls, missing or poorly maintained compliance handling procedures, inadequate employee training, and insufficient auditing procedures, according to a whitepaper on the subject produced by Siemens PLM Software in conjunction with Tata Consultancy Services.

"Medical device makers are required to document and show traceability from the first phone call when they had the idea, to what decisions were made on what basis when they started designing," to years out after the product has been in the field, Schroer said. "Most companies throw away that first stuff because it's (often) not relevant. In medical devices, it is."

My question is rather pointy, which is: what is the claimed value of having all of those records about every step pf the product design and development? Why should every design decision be placed where it can be second guessed? Most importantly, WHO will obtain the alleged value of all of this rather expensive and complicated to keep documentation? Is it being saved up as fuel for malpractice suits? Or as defense from them?

How about a truthful explanation of just why all these records are so very important.

About 20 years ago, Design News did a story about a new implantable defibrillator from Medtronic. For the story, Medtronic photographed one of its employees standing next to a pile of compliance documentation. The pile was a couple of feet taller than the employee, and I'm sure it has gotten much worse over the past two decades.

Life safety give certain organizations clout to demand whatever they want. Since, they can pull that card at any moment, of course medical design companies are getting mad. Since new tech is being created every day in the industry, regulation is a must. Otherwise, we would still have x-ray machines at the shoe store. Those medical companies bought the ticket, they take the ride. (Hunter S. Thompson quote)

Great article with good information. It really is surprising how much PLM is in its infancy in this highly regulated industry.

naperlou you are correct, aerospace companies have relied on PLM for decades to reduce risk and track their development/compliance. These tools are very much needed for the medical community and hopefully companies can adopt these solutions to keep innovation moving forward.

Beth, the compliance issue is an important one. As many engineered products are used in life critical situations, compliance is important. It is important not just for satisfying some external authority, but for serving customers.

That said, this applies to many industries. Avionics is one obvious one. The standards for various industries are generally separate and generally very similar. Thus, PLM vendors, who typically work across industries, can bring this knowledge to bear on new areas of opportunity. Now, if the companies would be smart and look for people with a different, but similar, compliance problem, they might find it easier to comply.

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